Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data.

1. 2-day In-person Seminar:
Knowledge, a Way Forward…
Validation, Verification and Transfer of Analytical Methods
(Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Zurich, Switzerland
March 20th & 21st, 2017
9:00 AM to 6:00 PM
Ludwig Huber
Price: $1,695.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
Overview :
Global
CompliancePanel
Analytical methods and procedures should be validated to ensure
reliability, consistency and accuracy of analytical data. Compendial
methods should be verified to demonstrate the suitability of
laboratories to successfully run the method and when methods are
transferred between laboratories successful transfer should be
demonstrated through testing. In case a laboratory wants to use an
alternative method instead of a compendial method, equivalency of
the alternative method to the compendial method should be
demonstrated.
$8,475.00
Price: $5,085.00 You Save: $3,390.0 (40%)*
Register for 5 attendees
Chief Advisor - Global FDA compliance, Labcompliance
 Chairman, presenter and panel discussion member at US-FDA
Industry Training sessions and conferences
 Served as team member of PDA's task forces "21 CFR Part 11",
of US-FDA internal documents, and of the GAMP® special
interest group on Laboratory Systems.
 Presenter of the Year of the Institute for Validation and
Technology
 Director and chief editor of www.labcompliance.com, the global
on-line resource for validation and compliance issues for
laboratories.
 Author of the books "Validation and Qualification in Analytical
Laboratories, and "Validation of Computerized Analytical and
Networked Systems”
ENROLL

2. Global
CompliancePanel
Agenda:
Day One Day Two
2-day In-person Seminar:
Validation, Verification and Transfer of Analytical Methods
(Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Lecture 1: Regulatory Background and Requirements
FDA and international requirements
The importance of ICH Q2 and USP chapters
USP approach for method validation:
New/revised Chapters 220, 1200, 1210, 1220,
1225
Learnings from the NEW FDA and WHO
method validation guidelines
Different requirements for GLP, GCP and GMP
The importance and steps of risk assessment
Exercise: Define risk numbers for different
methods
Lessons from recent FDA Warning Letters
Planning for cost-effective implementation
Lectures and Workshop Exercises
Lecture 2: Preparing Your Lab for Validation Studies
Analytical Instrument qualification
Part 11/Annex 11 compliance of computer
systems
Validation of chromatographic data systems
Validation and control of Excel spreadsheets
Qualification of reference standards and
materials
Lecture 3: Validation of Analytical Methods and Procedures
Developing a validation plan and SOP
ICH Q2 validation and test parameters:
Accuracy, precision, intermediate precision,
specificity, LOD, LOQ, linearity, range,
robustness, ruggedness
Examples for application specific acceptance
criteria
Examples for design and execution of test
experiments
Evaluation of test results: using statistical
models
Handling deviations from expected test results
Going through an example validation report
Lecture 4: Verification of Compendial Methods
FDA and equivalent international expectations
Scope and objectives of USP <1226>
USP <1226> verification requirements
Risk based approach for type and extent of
verification testing
Which validation parameters should be verified
Logical process to set acceptance criteria
Exercise: Application based verification testing
Lecture 1: Transfer of Analytical Methods and Procedures
The main objective of formal method transfer
Learnings from EU GMP Chapter 6 on method
transfer
USP <1224> : Choosing the approach for
transfer
Approach and benefits of comparative testing:
Developing a risk based test plan
Planning and developing an effective transfer
protocol
Preparing the receiving lab for the transfer
Method transfer to new technology:: HPLC to
UHPLC
Preparing the method transfer report
Exercise: Application specific comparative
testing
Lectures and Workshop Exercises
Lecture 2: Demonstrating Equivalency to Compendial
Methods
Method validation vs. equivalency testing
Definition, objective and scope of alternative
methods
Justification for the use of alternative methods
FDA and USP requirements
Options for alternatives to approved
procedures
Exercise: Equivalency testing - what and how
much
Documentation requirements
Lecture 3: Maintaining the Validated State
Monitoring method performance: system
suitability testing and quality control samples
Change control procedure for analytical
methods
Handling method changes vs. adjustments
Revalidation of analytical methods: when, what
to test
Method reviews as a cost effective alternative
to time based revalidation
Going through a review process
Regulatory reporting of post-approval changes
Examples for continuous improvements
Lecture 4: Special Applications and Validation Processes
Preview to the expected new USP general
chapter <1220> "The Analytical Procedure
Lifecycle”
Method development and validation using
Quality by Design principles following the new
FDA Guidance
Validation of bioanalytical methods according
to the FDA and EMA guidelines
Validation of stability indication method

3. Global
CompliancePanel
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Post event email assistance to your queries.
Special price on future purchase of web
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Special price on future consulting or expertise
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Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
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2-day In-person Seminar:
Validation, Verification and Transfer of Analytical Methods
(Understanding and implementing guidelines from FDA/EMA, USP and ICH)